Markings - Interacoustics Eclipse EP15 Instructions For Use Manual

2.2 Markings

The following markings can be found on the instrument:
Symbol
0123
REF
I
O
D-0120588-B – 2019/03
Eclipse – Instructions for Use - EN
Explanation
Type B applied parts.
This is used for parts applied to the patient that require only ordinary electrical
protection e.g., headphones.
Type BF applied parts.
This is used for parts applied to the patient that require a higher degree of
electrical protection e.g., patient coupled electrodes.
Follow Instructions for Use
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive
93/42/EEC. TÜV Product Service, Identification No. 0123,
has approved the quality system.
Year of manufacture.
Manufacturer
Serial number
Reference number
Indicates that a component is intended for one use, or for use on a single
patient during a single procedure
On (Power: connection to the mains).
Off (Power: disconnection from the mains).
Equipotentiality is used to ground metal parts, e.g. the frame underneath a
patient bed. This will reduce the noise pick up by patient. Use the
Equipotentiality cable which is included in the Eclipse shipment.
Keep dry
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